This phase IV trial evaluates the genetic characteristics of African ancestry and environmental characteristics that may be related to the effects, both good and bad, of niraparib in women with stage III-IV ovarian cancer, fallopian tube cancer and primary peritoneal cancer following front-line treatment. Treatment usually includes surgery and chemotherapy and sometimes may also include treatment to keep the cancer from coming back (maintenance treatment). However, maintenance treatment may not work the same for everyone for many reasons, including race or ethnicity. Genes are made up of deoxyribonucleic acid (DNA) which acts as the instruction book for the cells in the body. Genes are inherited from parents and control how the body grows and changes as well as how the body reacts to certain things, such as medications. Niraparib blocks an enzyme involved in many cell functions, including the repair of DNA damage. Blocking this enzyme may help keep tumor cells from repairing their damaged DNA, causing them to die. Niraparib is a type of poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor. Giving niraparib may be safe, tolerable, and/or effective in treating women of African ancestry with stage III-IV ovarian cancer, fallopian tube cancer or primary peritoneal cancer following front-line treatment.
Additional locations may be listed on ClinicalTrials.gov for NCT06412120.
Locations matching your search criteria
United States
Florida
Miami
University of Miami Miller School of Medicine-Sylvester Cancer CenterStatus: Active
Contact: Matthew Peter Schlumbrecht
Phone: 305-243-2233
PRIMARY OBJECTIVE:
I. To evaluate the safety and tolerability of maintenance niraparib tosylate monohydrate (niraparib) treatment in women of African ancestry.
SECONDARY OBJECTIVES:
I. To evaluate the following additional safety endpoints:
Ia. Any grade and grade 3 or higher adverse event (AE) regardless of treatment attribution;
Ib. Any grade and grade 3 or higher treatment-related adverse event (TRAE);
Ic. Serious adverse event (SAE) of any treatment attribution;
Id. AE/SAE leading to treatment discontinuation, AE/SAE leading to dose reduction, AE/SAE leading to dose interruption, and AE/SAE leading to death.
II. To evaluate the clinical benefit as measured by recurrence-free survival (RFS) and CA-125 trends.
III. To evaluate ovarian cancer-specific health-related quality-of-life (HRQoL) and patient reported outcomes (PROs).
IV. To evaluate pharmacokinetics (PK) of niraparib as it relates to measured African ancestry.
EXPLORATORY OBJECTIVES:
I. To identify biomarkers for PARP inhibitor (PARPi) resistance via determining the genomic landscape and prevalence of homologous recombination deficient (HRD), homologous recombination deficient-proficient (HRD-P), and homologous recombination proficiency (HRP) by comparison of germline and somatic mutations in Black women with ovarian cancer.
II. To identify African ancestry-specific single nucleotide polymorphisms (SNPs) that predict drug metabolism and secondary effects (pharmacogenomics).
III. To measure quantities of circulating tumor DNA (ctDNA) in serum of participants.
OUTLINE:
Patients receive niraparib orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with continued response after 24 cycles may continue niraparib at the discretion of treating physician. Patients also undergo blood sample collection throughout the study. Additionally, patients may also undergo computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT at screening and per investigator discretion.
After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 1 year.
Lead OrganizationUniversity of Miami Miller School of Medicine-Sylvester Cancer Center
Principal InvestigatorMatthew Peter Schlumbrecht